Yoder, et al v. Town of Morristown, et al

Filing 105

MOTION to Amend/Correct 13 Answer to Complaint to clarify and supplement an affirmative defense Motion Hearing set for 4/3/2012 11:00 AM in Albany before Senior Judge Neal P. McCurn Response to Motion due by 3/19/2012 filed by Mark Blanchard, Christopher Coffin, Lanetta Kay Davis, Frank L. Putman, David Stout, III, Town of Morristown, Gary Turner, Howard Warren. (Attachments: # 1 Declaration Laws Declaration, # 2 Exhibit(s) A, # 3 Exhibit(s) B, # 4 Exhibit(s) C, # 5 Exhibit(s) D, # 6 Memorandum of Law, # 7 Appendix unreported case, # 8 Appendix unreported case, # 9 Appendix unreported case, # 10 Appendix unreported case, # 11 Appendix unreported case, # 12 Appendix unreported case, # 13 Appendix unreported case, # 14 Appendix unreported case, # 15 Affidavit certificate of service) Motions referred to Therese Wiley Dancks. (Laws, April)

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Caution
As of: Feb 17, 2012
NYCOMED US INC., Plaintiff, -against- GLENMARK GENERICS LTD., et al.,
Defendants.
08-CV-5023 (CBA)(RLM)
UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW
YORK
2010 U.S. Dist. LEXIS 29267

March 26, 2010, Decided
March 26, 2010, Filed
SUBSEQUENT HISTORY: Later proceeding at
Nycomed US, Inc. v. Glenmark Generics, Inc., 2010 U.S.
Dist. LEXIS 33090 (E.D.N.Y., Apr. 5, 2010)
Related proceeding at Glenmark Pharmaceuticals, S.A. v.
Nycomed U.S., Inc., 2010 N.Y. Misc. LEXIS 2046 (N.Y.
Sup. Ct., Apr. 23, 2010)
PRIOR HISTORY: Nycomed US, Inc. v. Glenmark
Generics, Inc., 2010 U.S. Dist. LEXIS 20788 (E.D.N.Y.,
Mar. 8, 2010)
CASE SUMMARY:

PROCEDURAL POSTURE: Plaintiff pharmaceutical
company sued defendant pharmaceutical companies
alleging patent infringement. Plaintiff moved to amend to
assert claims for bad faith, unclean hands, and
exceptional case. Defendants opposed the motion and
moved to file an amended answer alleging inequitable
conduct before the Patent and Trademark Office (PTO).
The motions were referred to a magistrate for a ruling and
for issuance of a report and recommendation.

OVERVIEW: Plaintiff alleged that defendants infringed
its patent by seeking approval to market a generic lotion.
Defendants denied liability and asserted affirmative
defenses and counterclaims. Finding that an exceptional
case was not an independent claim, but merely the basis
for attorneys' fees in a patent suit, the magistrate granted
plaintiff Fed. R. Civ. P. 15(a) leave to amend to seek
attorneys' fees. However, the magistrate otherwise
recommended denying plaintiff leave to amend, finding
that its claim for willful infringement based on
incorporating by reference a prior pleading did not
contain any specific factual allegations, and in any event,
such an amendment would be futile since defendants had
not engaged in any asserted unlawful activities with
respect to the patent. Plaintiffs' unclean hands and bad
faith claims were more properly presented on a motion
for fees if plaintiff prevailed. However, the court granted
defendants' Rule 15(a) motion to amend to allege
inequitable conduct before the PTO, finding that the
motion was timely, defendants were diligent, and plaintiff
failed to establish prejudice from granting the motion or
that such an amendment would be futile.

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2010 U.S. Dist. LEXIS 29267, *

OUTCOME: The magistrate granted plaintiff's motion
to amend only to permit it to add a request for attorneys'
fees; the magistrate otherwise recommended denying
plaintiff's motion to amend. The court granted defendants'
motion to amend their answer and reopened discovery for
the limited purpose of allowing plaintiff take discovery
regarding defendants' newly added inequitable conduct
allegation.

"exceptional case" is simply noting its intention to move
for attorney fees at the conclusion of the case, pursuant to
35 U.S.C.S. § 285.
Civil Procedure > Pleading & Practice > Pleadings >
Amended Pleadings > Leave of Court
[HN4] That amendments would not serve any purpose is
a valid ground to deny a motion for leave to amend.

LexisNexis(R) Headnotes

Civil Procedure > Pleading & Practice > Pleadings >
Amended Pleadings > Leave of Court
Civil Procedure > Judicial Officers > Judges >
Discretion
[HN1] Pursuant to Fed. R. Civ. P. 15, where a responsive
pleading has already been filed, a party may amend its
pleading only with the opposing party's written consent
or the court's leave, which should be freely granted when
justice so requires Fed. R. Civ. P. 15(a)(2). Amendments
are favored because they tend to facilitate a proper
decision on the merits. Mere technicalities should not
prevent cases from being decided on the merits.
Consistent with Rule 15's mandate, leave to amend
should be granted absent evidence of undue delay, bad
faith or dilatory motive on the part of the movant, undue
prejudice to the opposing party, or futility. Whether to
grant leave to amend is a decision committed to the
discretion of the district court.
Civil Procedure > Pleading & Practice > Defenses,
Demurrers & Objections > Failures to State Claims
Civil Procedure > Pleading & Practice > Pleadings >
Amended Pleadings > Leave of Court
[HN2] Futility is one of the grounds on which leave to
amend a pleading should be denied. An amendment is
futile where it fails to state a claim under the principles
employed by the court when deciding on a Fed. R. Civ. P.
12(b)(6) motion to dismiss. Leave to file an amended
pleading must be denied where the proposed pleading
fails to state a claim.
Patent Law > Remedies > Collateral Assessments >
Attorney Fees
[HN3] Allegations regarding exceptional case do not give
rise to a separate cause of action; rather, a party pleading

Civil Procedure > Pleading & Practice > Pleadings >
Complaints > General Overview
Civil Procedure > Pleading & Practice > Pleadings >
Rule Application & Interpretation
[HN5] Although there is no prescribed procedure for
referring to incorporated matter, references to prior
allegations must be direct and explicit, in order to enable
a responding party to ascertain the nature and extent of
the incorporation. A Rule Fed. R. Civ. P. 10(c) adoption
clause that does little more than make wholesale
reference to the contents of a prior pleading exemplifies
the kind of incorporation that fails to give the requisite
guidance to the responding party.
Patent Law > Infringement Actions > Infringing Acts >
General Overview
Patent Law > Remedies > Collateral Assessments >
Increased Damages
[HN6] The tort of willful infringement arises upon
deliberate disregard for the property rights of the patentee
and, if proven, may be accompanied by enhanced
damages under 35 U.S.C.S. § 284.
Governments > Agriculture & Food > Federal Food,
Drug & Cosmetic Act
Patent Law > Remedies > Damages > General Overview
[HN7] The Hatch-Waxman Act--which amends the
Federal Food, Drug and Cosmetics Act and patent
laws--expressly precludes damages or other monetary
relief for an act of infringement based on an abbreviated
new drug application filing or certification unless there
has been commercial manufacture, use, offer to sell, or
sale within the United States or importation into the
United States of an approved drug. 35 U.S.C.S. §
271(e)(4)(C).
Civil Procedure > Sanctions > Misconduct & Unethical
Behavior > General Overview

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2010 U.S. Dist. LEXIS 29267, *

Patent Law > Infringement Actions > Infringing Acts >
General Overview
Patent Law > Remedies > Collateral Assessments >
Attorney Fees
[HN8] Litigation misconduct is entirely distinct from
willful infringement. Willful infringement is but one of a
number of bases on which a court may make an
"exceptional case" finding and award fees under 35
U.S.C.S. § 285.
Civil Procedure > Sanctions > Misconduct & Unethical
Behavior > General Overview
Governments > Agriculture & Food > Federal Food,
Drug & Cosmetic Act
[HN9] The U.S. Court of Appeals for the Federal Circuit
has expressly declined to equate willful infringement
with filing an infringing, and even a baseless, abbreviated
new drug application, even when followed by litigation
misconduct.
Administrative Law > Judicial Review > Reviewability >
Preclusion
Governments > Agriculture & Food > Federal Food,
Drug & Cosmetic Act
[HN10] Private parties cannot bring actions for
misconduct before the U.S. Food and Drug
Administration (FDA) under the guise of the
Hatch-Waxman
Act.
The
provision
of
the
Hatch-Waxman Act governing certifications by
abbreviated new drug application filers cannot be
enforced by a private party in a patent infringement
action, but must be enforced, if at all, only in the context
of an action under the Administrative Procedure Act.
Patent Law > Infringement Actions > Infringing Acts >
General Overview
Patent Law > Remedies > Equitable Relief >
Injunctions
Patent Law > Statutory Bars > Experimental Use >
General Overview
[HN11] 35 U.S.C.S. § 271(e)(4)(B) provides that
injunctive relief may be granted against an infringer to
prevent the commercial manufacture, use, offer to sell, or
sale within the United States or importation into the
United States of an approved drug. 35 U.S.C.S. §
271(e)(4)(B).

Administrative Law > Judicial Review > Reviewability >
Preclusion
Governments > Legislation > Statutory Remedies &
Rights
[HN12] Private rights of action to enforce federal law
must be created by Congress, and a court's search for
congressional intent begins and often ends with the text
and structure of the statute at issue. Where the statute
empowers an agency to enforce its regulations, a court
will not assume that Congress intended to authorize by
implication additional judicial remedies for private
citizens suing to enforce those regulations.
Civil Procedure > Pleading & Practice > Defenses,
Demurrers & Objections > Motions to Dismiss
Civil Procedure > Pleading & Practice > Defenses,
Demurrers & Objections > Motions to Strike >
Immaterial Matters
Civil Procedure > Pleading & Practice > Defenses,
Demurrers & Objections > Motions to Strike >
Redundant Matters
Civil Procedure > Pleading & Practice > Pleadings >
Complaints > Requirements
[HN13] Fed. R. Civ. P. 8 requires that a complaint
contain a short and plain statement of the claim showing
that the pleader is entitled to relief. Fed. R. Civ. P.
8(a)(2). The statement should be short because
unnecessary prolixity in a pleading places an unjustified
burden on the court and the party who must respond to it
because they are forced to select the relevant material
from a mass of verbiage. To ameliorate this problem, a
district court has the power, on its own initiative or in
response to a motion by the defendant, to strike any
portions of a pleading that are redundant or immaterial,
Fed. R. Civ. P. 12(f), or to dismiss the complaint.
Civil Procedure > Pretrial Matters > Conferences >
Scheduling Conferences
[HN14] Fed. R. Civ. P. 16(b) provides that scheduling
orders--including provisions limiting the time for
amending the pleadings--may be modified only for good
cause and with the judge's consent. Fed. R. Civ. P. 16(b).
Civil Procedure > Pleading & Practice > Pleadings >
Amended Pleadings > Leave of Court
Civil Procedure > Pretrial Matters > Conferences >
Scheduling Conferences
[HN15] Despite the lenient standard of Fed. R. Civ. P.

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2010 U.S. Dist. LEXIS 29267, *

15(a), a district court does not abuse its discretion in
denying leave to amend the pleadings after the deadline
set in the scheduling order where the moving party has
failed to establish good cause.
Civil Procedure > Pleading & Practice > Pleadings >
Amended Pleadings > Leave of Court
Civil Procedure > Pretrial Matters > Conferences >
Scheduling Conferences
[HN16] The U.S. Court of Appeals for the Second Circuit
in Parker did not mandate that the "good cause" standard
automatically apply in every case, but rather, upheld a
trial court's discretion to deny a late application for
failing to meet the "good cause" requirement under Fed.
R. Civ. P. 16(b). A moving party's diligence is not the
only consideration, and a district court, in exercising its
discretion under Rule 16(b), also may consider other
relevant factors including, in particular, whether allowing
an amendment of the pleading at this stage of the
litigation will prejudice the opposing party.
Civil Procedure > Pleading & Practice > Pleadings >
Amended Pleadings > Leave of Court
Evidence > Procedural Considerations > Burdens of
Proof > Allocation
[HN17] A party opposing the motion for leave to amend
has the burden of establishing that an amendment would
be prejudicial.
Civil Procedure > Pleading & Practice > Pleadings >
Amended Pleadings > Leave of Court
[HN18] The type of prejudice that warrants denial of
leave to amend is usually such that it puts the opposing
party at an unfair disadvantage, such as the addition of a
new claim on the eve of trial. In this regard, the need to
conduct additional discovery is not, in itself, sufficient to
constitute prejudice. The fact that one party has spent
time and money preparing for trial will usually not be
deemed prejudice sufficient to warrant a deviation from
the rule broadly allowing amendment to pleadings. This
principle applies with particular force where trial has not
yet commenced and is not likely to do so for some time.
The fact that discovery has ended does not alter this
conclusion. The prejudice that would flow from any
additional required discovery can generally be mitigated
by adjustments to the discovery schedule.

Civil Procedure > Pleading & Practice > Pleadings >
Amended Pleadings > Leave of Court
Evidence > Procedural Considerations > Burdens of
Proof > Allocation
[HN19] A party opposing an amendment has the burden
of establishing that leave to amend would be prejudicial
or futile.
Civil Procedure > Pleading & Practice > Pleadings >
Heightened Pleading Requirements > Fraud Claims
Patent Law > Inequitable Conduct > General Overview
Patent Law > U.S. Patent & Trademark Office
Proceedings > General Overview
[HN20] Fed. R. Civ. P. 9(b) requires identification of the
specific who, what, when, where and how of the material
misrepresentation or omission committed before the
Patent and Trademark Office (PTO). Although
knowledge and intent may be averred generally, a
pleading of inequitable conduct under Rule 9(b) must
include sufficient allegations of underlying facts from
which a court may reasonably infer that a specific
individual (1) knew of the withheld material information
or of the falsity of the material misrepresentation, and (2)
withheld or misrepresented this information with a
specific intent to deceive the PTO. A pleading that simply
avers the substantive elements of inequitable conduct,
without setting forth the particularized factual bases for
the allegation, does not satisfy Rule 9(b).
Patent Law > Inequitable Conduct > Effect, Materiality
& Scienter > Elements
[HN21] Information is considered material where either
(a) there is a substantial likelihood that a reasonable
examiner would consider it important in deciding
whether to allow the application to issue as a patent, 37
C.F.R. § 1.56(a) (1991); or (b) it falls within the
standards set forth in Patent and Trademark Office Rule
56, which provides that information is material to
patentability when it is not cumulative to information
already of record or being made of record in the
application, and (2) it refutes, or is inconsistent with, a
position the applicant takes in: (i) opposing an argument
of unpatentability relied on by the Patent and Trademark
Office, or (ii) asserting an argument of patentability.
Evidence > Inferences & Presumptions > Inferences
Evidence > Procedural Considerations > Circumstantial
& Direct Evidence

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2010 U.S. Dist. LEXIS 29267, *

Patent Law > Inequitable Conduct > Effect, Materiality
& Scienter > General Overview
[HN22] In a patent case, intent rarely can be, and need
not be, proven by direct evidence. Instead, an intent to
deceive is usually inferred from the facts and
circumstances surrounding the conduct at issue.
Furthermore, the more material the omission or the
misrepresentation, the lower the level of intent required
to establish inequitable conduct, and vice versa.
Evidence > Inferences & Presumptions > Inferences
Patent Law > Inequitable Conduct > Effect, Materiality
& Scienter > General Overview
[HN23] Intent may be inferred where a patent applicant
knew that withheld information would be material to the
Patent and Trademark Office's consideration of the patent
application, especially where the examiner repeatedly
raises an issue to which the information relates.
Civil Procedure > Pleading & Practice > Pleadings >
Amended Pleadings > Leave of Court
[HN24] In making a determination on a motion for leave
to amend, a court should not consider the merits of a
claim or defense unless the amendment is clearly
frivolous or legally insufficient on its face. If the movant
has at least colorable grounds for relief, justice requires
that the court grant leave to amend.
Civil Procedure > Pleading & Practice > Pleadings >
Heightened Pleading Requirements > Fraud Claims
Patent Law > Inequitable Conduct > General Overview
[HN25] The heightened pleading requirements of Fed. R.
Civ. P. 9(b) do not require that an alleged infringer prove
the merits of its claim. What is determinative is that the
patentee is given fair notice of the basis for the alleged
infringer's inequitable conduct defense.
COUNSEL: [*1] For Nycomed US Inc., Plaintiff:
Dmitry Shelhoff, LEAD ATTORNEY, Kramer Levin
Naftalis & Frankel, New York, NY; Donald Luther
Rhoads, Nicholas Lazaros Coch, LEAD ATTORNEYS,
Albert B. Chen, Benu Mehra, Matthew Fontaine Abbott,
Kramer Levin Naftalis & Frankel, LLP, New York, NY.
For Glenmark Generics LTD., Glenmark Generics Inc.,
USA, Defendants, Counter Claimants: Bradley Drew
Simon, LEAD ATTORNEY, Simon & Partners LLP,
New York, NY; Deirdre E. Sanders, LEAD

ATTORNEY, PRO HAC VICE, Brian T. Moriarty,
Hamilton, Brook, Smith & Reynolds, P.C., Concord,
MA; Maria L. Cedroni, LEAD ATTORNEY, PRO HAC
VICE, Hamilton, Brook, Smith & Reynolds, Concord,
MA.
For Nycomed US Inc., Counter Defendant: Dmitry
Shelhoff, LEAD ATTORNEY, Kramer Levin Naftalis &
Frankel, New York, NY; Donald Luther Rhoads,
Nicholas Lazaros Coch, LEAD ATTORNEYS, Albert B.
Chen, Matthew Fontaine Abbott, Kramer Levin Naftalis
& Frankel, LLP, New York, NY.
For Glenmark Generics LTD., Glenmark Generics Inc.,
USA, Counter Claimants: Brian T. Moriarty, LEAD
ATTORNEY, Hamilton Brook Smith & Reynolds, PC,
Concord, MA.
For Nycomed US Inc., Counter Defendant: Albert B.
Chen, Matthew Fontaine Abbott, Kramer Levin Naftalis
& Frankel, LLP, [*2] New York, NY.
JUDGES: ROANNE L. MANN, UNITED STATES
MAGISTRATE JUDGE.
OPINION BY: ROANNE L. MANN
OPINION

MEMORANDUM AND ORDER/REPORT AND
RECOMMENDATION
ROANNE L. MANN,
MAGISTRATE JUDGE:

UNITED

STATES

Plaintiff Nycomed U.S. Inc. ("Nycomed" or
"plaintiff") commenced this civil action on December 12,
2008, alleging that defendants Glenmark Generics Ltd.
and Glenmark Generics Inc., USA (collectively,
"Glenmark" or "defendant") infringed Nycomed's patent
for its Cutivate(R) Fluticasone Lotion 0.05%, U.S. Patent
No. 7,300,669 ("'669 Patent"), by seeking approval to
market a generic fluticasone lotion. See generally
Complaint ("Compl."), ECF Docket Entry ("D.E.") # 1.
On January 12, 2009, Glenmark filed its answer to the
complaint, denying liability and asserting four affirmative
defenses. See generally Answer ("Ans."), D.E. # 10.
Glenmark also counterclaimed for declarations that (1)
Glenmark's fluticasone lotion product does not infringe
any of the claims of the '669 Patent; (2) the '669 Patent is

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2010 U.S. Dist. LEXIS 29267, *2

invalid; (3) the '669 Patent is unenforceable on account
of Nycomed's inequitable conduct before the United
States Patent and Trademark Office ("PTO"); and (4) this
is an exceptional case, entitling Glenmark to attorney fees
[*3] under 35 U.S.C. § 285. See id. (Counterclaims) PP
144-52. In a reply filed on February 17, 2009, Nycomed
denied the allegations made in Glenmark's counterclaims.
See generally Nycomed's Reply to Defendants'
Counterclaims, D.E. # 32. With Nycomed's consent,
Glenmark amended its answer on July 24, 2009, to drop
its affirmative defense of laches; Glenmark's
counterclaims remained unchanged. See generally
Amended Answer ("Am. Ans."), D.E. # 108; Stipulation
Regarding Motion and Defense, D.E. # 104. Nycomed
filed its reply to Glenmark's amended pleading on August
10, 2009. See Reply to Defendants' Amended
Counterclaims ("8/10/09 Pl. Reply"), D.E. # 123.

Counterclaims ("11/13/09 Def. Mot.") at 1, D.E. # 190;
id. Ex. A (Defendants' [Proposed Second] Amended
Answer ("Second Am. Ans.")). Predictably, Nycomed
opposes the motion, arguing [*5] that it is "unduly
belated" and that the new inequitable conduct claim "fails
to meet the standards for pleading" such a claim "with
particularity . . . ." Response in Opposition to Letter
Motion for Leave to File Defendants' Second Amended
Answer ("11/18/09 Pl. Opp."), D.E. # 194.

By letter dated September 18, 2009, plaintiff sought
a pre-motion conference and leave to amend the
complaint, in order to assert claims for bad faith, unclean
hands, and exceptional case, based on Glenmark's
submission of allegedly "false and misleading
information" to the Food and Drug Administration
("FDA") and the "withholding of critical information
from the Court and Nycomed." See Plaintiff's Motion to
Amend/Correct/Supplement Complaint ("9/18/09 Pl.
Mot.") at 1, D.E. # 143; id. Ex. A ([Proposed] Amended
Complaint ("Am. Compl.")) PP [*4] 69, 78-149.
Nycomed supplemented its letter-motion by letter dated
November 20, 2009. See Reply to Response to Motion
("11/20/09 Pl. Supp."), D.E. # 195. Defendant opposes
Nycomed's motion to amend as futile, arguing that
Nycomed has failed to plead any cognizable causes of
action with regard to any of the prospective additional
claims. See Defendant's Response in Opposition to
Plaintiff's Motion to Amend ("9/29/09 Def. Opp."), D.E.
# 169.

1 The Second Circuit has characterized a motion
to amend as "nondispositive." See Fielding v.
Tollaksen, 510 F.3d 175, 178 (2d Cir. 2007).
Nevertheless, out of an abundance of caution, and
because this Court concludes that Nycomed's
proposed claims should be foreclosed, this
opinion has been designated as a Report and
Recommendation that Nycomed's motion to
amend to add those claims be denied, and as a
Memorandum and Order granting Glenmark's
motion to amend and granting Nycomed leave to
add a request for attorney fees in its prayer for
relief. See generally Schiller v. City of New York,
No. 04 Civ. 7922(RJS)(JCF), 2009 U.S. Dist.
LEXIS 15551, 2009 WL 497580, at *2 (S.D.N.Y.
Feb. 27, 2009); [*6] Wilson v. City of New York,
No. 06 Civ. 219 (ARR)(VVP), 2008 U.S. Dist.
LEXIS 35461, 2008 WL 1909212, at *3-4
(E.D.N.Y. Apr. 30, 2008) (collecting cases).

Not to be outdone, Glenmark wrote to the Court on
November 13, 2009, seeking leave to file a Second
Amended Answer, alleging a new theory of inequitable
conduct before the PTO; specifically, Nycomed is alleged
to have falsely told the PTO that Nycomed's Cutivate(R)
lotion possessed unexpected and superior potency as
compared with the prior art Cutivate(R) cream, despite
the fact that the FDA had been told that there was no
difference in potency between the cream and lotion. See
Letter Motion for Leave to File Defendants' Second
Amended Answer, Affirmative Defenses and

For the reasons that follow, Nycomed's motion to
amend its complaint is granted in limited part, to allow
Nycomed to include in its ad damnum clause an
allegation of exceptional case and request for attorney
fees; the Court recommends that Nycomed's motion to
amend otherwise be denied. Glenmark's motion to amend
its pleading is granted. 1

DISCUSSION
[HN1] Pursuant to Rule 15 of the Federal Rules of
Civil Procedure, where, as here, a responsive pleading
has already been filed, a party may amend its pleading
"only with the opposing party's written consent or the
court's leave[,]" which should be "freely" granted "when
justice so requires." Fed. R. Civ. P. 15(a)(2).
Amendments are favored because they "tend to facilitate
a proper decision on the merits." Sokolski v. Trans Union
Corp., 178 F.R.D. 393, 396 (E.D.N.Y. 1998) (internal
quotation marks and citations omitted); see also Monahan
v. New York City Dep't of Corr., 214 F.3d 275, 283 (2d

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2010 U.S. Dist. LEXIS 29267, *6

Cir. 2000) ("[M]ere technicalities should not prevent
cases from being decided on the merits[.]") (citations
omitted). Therefore, consistent with Rule 15's mandate,
leave to amend should be granted "absent evidence of
undue delay, bad faith or dilatory motive on the part of
the movant, undue prejudice to the opposing party, or
futility . . . ." Id. at 283 (citing Foman v. Davis, 371 U.S.
178, 182, 83 S. Ct. 227, 9 L. Ed. 2d 222 (1962)). [*7]
Whether to grant leave to amend is a decision committed
to the discretion of the district court. See Ruffolo v.
Oppenheimer & Co., 987 F.2d 129, 131 (2d Cir. 1993)
(per curiam) (quoting 3 James Wm. Moore et al., Moore's
Federal Practice P 15.08[4], at 15-64 (2d ed. 1992)).
I. Nycomed's Motion to Amend
In addition to its original claims for direct
infringement and inducement of infringement,
Nycomed's proposed new pleading contains two new
counts: one entitled "Bad Faith and Unclean Hands"
(Count Three) and another entitled "Exceptional Case"
(Count Four). See Am. Compl. at pp. 17, 31. Although
not expressly included in its amended pleading or initial
application to amend, Nycomed also purports to add
allegations of willful infringement. Compare Transcript
of Oral Argument on December 4, 2009 ("12/4/09 Tr.")
at 4, and 11/20/09 Pl. Supp. at 5-7, with 9/18/09 Pl. Mot.
& Ex. A thereto.
Glenmark opposes Nycomed's amendments, on the
ground that each of the proposed claims is futile. See
9/29/09 Def. Opp. at 1, 3. [HN2] Futility is one of the
grounds on which leave to amend a pleading should be
denied. See Monahan, 214 F.3d at 283 (citing Foman,
371 U.S. at 182). An amendment is futile where it "fails
[*8] to state a claim under the principles employed by the
Court when deciding on a Rule 12(b)(6) motion to
dismiss." Magee v. Paul Revere Life Ins. Co., 172 F.R.D.
647, 650 (E.D.N.Y. 1997) (citations omitted); see also
Champion Titanium Horseshoe, Inc. v. Wyman-Gordon
Inv. Castings, Inc., 925 F.Supp. 188, 189 (S.D.N.Y. 1996)
("[L]eave to file an amended pleading . . . must be denied
where the proposed pleading fails to state a claim.")
(citing Azurite Corp. v. Amster & Co., 52 F.3d 15, 19 (2d
Cir. 1995)).
As discussed below, this Court concludes that
Nycomed has not stated valid claims under any of the
three articulated theories.
A. Exceptional Case

Nycomed has conceded, as it must, that [HN3]
allegations regarding exceptional case do not give rise to
a separate cause of action; rather, a party pleading
"exceptional case" is simply noting its intention to move
for attorney fees at the conclusion of the case, pursuant to
35 U.S.C. § 285. 2 See Eli Lilly & Co. v. Wockhardt Ltd.,
Cause No. 1:08-cv-1547-WTL-TAB, 2009 U.S. Dist.
LEXIS 85934, 2009 WL 3032349, at *2 (S.D. Ind. Sept.
18, 2009) ("While the parties refer to Lilly's exceptional
case allegations as a 'claim,' the Court believes it is more
appropriate to view it as an [*9] expression of Lilly's
intention to file a § 285 motion following trial in the
event it is the prevailing party."); 11/20/09 Pl. Supp. at 3
(citing Wockhardt, Nycomed concedes that its
"exceptional case allegations are more appropriately
viewed as an expression of Nycomed's intention to file a
§ 285 motion following trial in the event that it is the
prevailing party"); 12/4/09 Tr. at 6 (Nycomed
acknowledged, at oral argument, that it would be
sufficient to include in the ad damnum clause a demand
for fees under section 285).
2
Section 285 provides that "[t]he court in
exceptional cases may award reasonable attorney
fees to the prevailing party" in patent cases. 35
U.S.C. § 285.
Nycomed should be permitted to amend its
complaint to include in its prayer for relief a demand for
attorney fees under section 285, as Glenmark has done in
each of its pleadings. See Ans. at p. 35; Am. Ans. at p.
35; Second Am. Ans. at p. 40. Nycomed's expression of
intent to move for fees requires no further verbiage in the
pleading. The Court is aware of no precedent that has
defined an assertion of "exceptional case" as a separate
cause of action. 3 Therefore, Nycomed should not be
permitted to include a separate [*10] count based on
exceptional case, or the allegations underlying that
nonexistent cause of action. 4 As the Second Circuit has
opined: [HN4] "That the amendments would not serve
any purpose is a valid ground to deny a motion for leave
to amend." Kaster v. Modification Sys., Inc., 731 F.2d
1014, 1018 (2d Cir. 1984). If and when Nycomed
prevails, it will have an opportunity to make the requisite
showing to support its motion for fees. 5
3
Plaintiff cites the case of Novartis
Pharmaceuticals Corp. v. Teva Pharmaceuticals
USA, Inc., No.Civ.A.05-CV-1887 (DM), 2005 U.S.
Dist. LEXIS 39341, 2005 WL 3664014 (D.N.J.

Page 8
2010 U.S. Dist. LEXIS 29267, *10

Dec. 30, 2005), in which a judge of the District of
New Jersey declined to strike allegations of
"willful infringement/ litigation misconduct," on
the ground that those allegations "support
[plaintiff's] request for exceptional case status . . .
." 2005 U.S. Dist. LEXIS 39341, [WL] at *2. That
decision rests on what this Court concludes is a
flawed view of "willful infringement" and
"exceptional case," see infra pp. 10-11, and its
reasoning has been rejected by other jurists,
including within the same district. See, e.g.,
Celgene Corp. v. Teva Pharms. USA, Inc., 412
F.Supp.2d 439, 444 (D.N.J. 2006).
4
For the same reason, Glenmark should, in
amending [*11] its pleading, drop its fourth
counter-claim,
entitled
"Declaration
of
Exceptional Case." See Second Am. Ans.
(Counterclaims) PP 153-54; see also 12/4/09 Tr.
at 40 (Glenmark agrees at oral argument that
exceptional case is "not something that needs to
be pled").
5 The Court declines the parties' invitation to
address the merits of Nycomed's allegations of
misconduct, see 9/29/09 Def. Opp. at 2; 11/20/09
Pl. Supp. at 4 -- an issue better left for a later day.

Counterclaims,' as if fully set forth herein." Am. Compl.
P 69. See 11/20/09 Pl. Supp. at 5-6; 12/4/09 Tr. at 3-4.
6 Rule 10(c) provides, in pertinent part, that
"statement[s] in a pleading may be adopted by
reference elsewhere in the same pleading or in
any other pleading or motion." Fed. R. Civ. P.
10(c).

1. Incorporation By Reference

Nycomed's incorporation-by-reference argument is
unavailing. [HN5] "Although there is no prescribed
procedure for referring to incorporated matter, the
references to prior allegations must be direct and explicit,
in order to enable the responding party to ascertain the
nature and extent of the incorporation." United States v.
Int'l Longshoremen's Ass'n, 518 F.Supp.2d 422, 461
(E.D.N.Y. 2007) (quoting 5A WRIGHT & MILLER,
FEDERAL PRACTICE & PROCEDURE: CIVIL 3d §
1326 (citing, inter alia, Arce v. Walker, 139 F.3d 329,
336 n.7 (2d Cir. 1998))). A Rule 10(c) adoption clause
[*13] that does little more than make wholesale reference
to the contents of a prior pleading exemplifies the kind of
incorporation that fails to give the requisite "guidance to
the responding party." Wolfe v. Charter Forest
Behavioral Health Sys., Inc., 185 F.R.D. 225, 229 (W.D.
La. 1999); accord Hinton v. Trans Union, LLC, 654
F.Supp.2d 440, 447-48 (E.D. Va. 2009); see Levitch v.
Columbia Broadcasting System, Inc., 94 F.R.D. 292, 295
(S.D.N.Y. 1982).

Although Nycomed's proposed amended complaint
and letter-motion of September 18th are silent on the
issue of willful infringement, Nycomed alleges in its
November 20th supplemental letter, and confirmed at oral
argument, that it purports to assert a claim of willful
infringement. See 11/20/09 Pl. Supp. at 5-7; 12/4/09 Tr.
at 3. Unable to fathom the precise contours of Nycomed's
willful infringement claim, the Court infers that it is
based at least in part on what Nycomed characterizes as
Glenmark's litigation misconduct. See 11/20/09 Pl. Supp.
at 5 (citing Novartis Pharms. v. Teva Pharms., 2005 U.S.
Dist. LEXIS 39341, 2005 WL 3664014 (discussing
plaintiff's "claim of willful infringement/litigation
misconduct")). [*12] In order to read a willful
infringement claim into its amended complaint, Nycomed
relies on Rule 10(c) of the Federal Rules of Civil
Procedure, 6 and a single sentence in the proposed
pleading, wherein Nycomed "incorporates the subject
matter of its August 10, 2009 pleading entitled,
'Nycomed's Reply to Defendants' Amended

Here, Nycomed purports to incorporate "the subject
matter" of its August 10, 2009 Reply, by an adoption
clause arbitrarily inserted at the end of its fact discussion,
immediately preceding the declaration of its first claim
for direct infringement. See Am. Compl. P 69. Most of
the averments in the incorporated pleading make no
specific factual allegations, but instead include denials of
allegations in defendant's counterclaims. See generally
8/10/09 Pl. Reply, D.E. # 123. To be sure, some of these
denials include language alluding to "evidence of
Glenmark's willful infringement" in submitting its
Abbreviated New Drug Application ("ANDA") to the
FDA. See 8/10/09 Pl. Reply PP 49, 50, 55-70, 72, 76-78,
82-93, 98-99, 101-02, 146, 148-50. Nevertheless, [*14]
none of Nycomed's pleadings articulates a separate claim
for willful infringement, and surely not one based on
litigation misconduct. The wholesale incorporation of
Nycomed's 8/10/09 Reply thus makes it impossible to
ascertain precisely which previously asserted facts are
being realleged and for what purpose. 7 Such an

B. Willful Infringement

Page 9
2010 U.S. Dist. LEXIS 29267, *14

obfuscating "backdoor" approach to pleading should not
be countenanced, notwithstanding Rule 10(c)'s broader
objective "to encourage pleadings that are short and free
of unneeded repetition." Wolfe, 185 F.R.D. at 230.
Nycomed's proposed amended complaint does not
contain a claim for willful infringement, and Nycomed
should not be permitted to concoct one by incorporating
its entire prior pleading.
7
Moreover, as the Court observed at oral
argument, Nycomed's 8/10/09 Reply will be
superseded once Nycomed and Glenmark file
amended pleadings. See Levitch, 94 F.R.D. at 294
("After the filing of an amended pleading prior
pleadings are deemed withdrawn unless
specifically referred to."); 12/4/09 Tr. at 8.
2. Willful Infringement vs. Exceptional Case
In any event, even if Nycomed had expressly pled a
cause of action for willful infringement, this Court would
recommend that it be [*15] disallowed. Nycomed
concedes that such a claim would be "surplusage" in this
case. See 12/4/09 Tr. at 6, 18. Moreover, it appears that
Nycomed misapprehends the gist of a claim for willful
infringement.
As the Federal Circuit has explained, [HN6] "[t]he
tort of willful infringement arises upon deliberate
disregard for the property rights of the patentee" and, if
proven, "may be accompanied by enhanced damages"
under 35 U.S.C. § 284. Vulcan Eng'g Co. v. Fata
Aluminium, Inc., 278 F.3d 1366, 1378 (Fed. Cir. 2002);
see also Yarway Corp. v. Eur-Control USA, Inc., 775
F.2d 268, 277 (Fed. Cir. 1985). Here, however, [HN7]
the Hatch-Waxman Act -- which amends the Federal
Food, Drug and Cosmetics Act ("FFDCA") and patent
laws, and under which this patent infringement action
was brought -- expressly precludes "damages or other
monetary relief" for an act of infringement based on an
ANDA filing or certification unless "there has been
commercial manufacture, use, offer to sell, or sale within
the United States or importation into the United States of
an approved drug . . . ." 35 U.S.C. § 271(e)(4)(C). 8 As it
is undisputed that Glenmark has not engaged in any of
the aforementioned activities, Nycomed will not [*16]
recover damages if it prevails, and there thus can be no
damages to enhance under section 284 based on a finding
of willfulness. See 12/4/09 Tr. at 5. Therefore,
Nycomed's "claim" of willfulness is of no discernible
legal import.

8 Even absent such activities, however, "a court
may award attorney fees under section 285" in
exceptional cases. 35 U.S.C. § 271(e)(4).
Furthermore, relying on Novartis Pharmaceuticals v.
Teva Pharmaceuticals, 2005 U.S. Dist. LEXIS 39341,
2005 WL 3664014, 9 Nycomed mistakenly equates
"willful infringement" with "exceptional case" and
assumes that litigation misconduct may support a finding
of willful infringement. See 11/20/09 Pl. Supp. at 5. In
fact, the Federal Circuit has made clear that those
concepts are not interchangeable, and that [HN8]
litigation misconduct is entirely distinct from willful
infringement. See Glaxo Group Ltd. v. Apotex, Inc., 376
F.3d 1339, 1350 (Fed. Cir. 2004) ("This court has
recognized many types of misconduct that may create an
exceptional case for purposes of awarding fees, including
inequitable conduct before the PTO, litigation
misconduct such as vexatious or unjustified litigation or
frivolous filings, and willful infringement.") (emphasis
added); accord Yamanouchi Pharm. Co. v. Danbury
Pharmacal, Inc., 231 F.3d 1339, 1346-47 (Fed. Cir.
2000). [*17] In other words, willful infringement is but
one of a number of bases on which a court may make an
"exceptional case" finding and award fees under 35
U.S.C. § 285. See Yamanouchi, 231 F.3d at 1347 ("In
assessing whether a case qualifies as exceptional, the
district court must look at the totality of the
circumstances.").
9 See supra note 3.
Contrary to the premise of Nycomed's theory of
willful infringement, [HN9] the Federal Circuit has
expressly declined to equate willful infringement with
filing an infringing (and even a baseless) ANDA, even
when followed by litigation misconduct. In Glaxo Group,
the Federal Circuit clarified its earlier opinion in
Yamanouchi:
In Yamanouchi, the district court had
found that the generic company's ANDA
filing constituted willful infringement, but
we did not adopt that rationale on appeal.
Instead we cautioned that the trial court
"need not have elevated the ANDA
certification into a finding of willful
infringement" and held that Danbury's
entire conduct justified the award of
attorney's fees . . . . Therefore, in

Page 10
2010 U.S. Dist. LEXIS 29267, *17

Yamanouchi, we did not agree that the
generic company had engaged in willful
infringement, but rather determined that an
award of attorney's fees [*18] was
permitted because the generic had filed
numerous baseless filings supporting its
fruitless and meritless arguments, both in
its case at trial and in its ANDA
certification. Such unjustified litigation
and misconduct has always justified a
finding of an exceptional case.
Glaxo Group, 376 F.3d at 1350 (citations omitted).
As previously noted, and consistent with the
rationale of Glaxo Group, Nycomed is entitled to amend
its complaint to express its intent to pursue an award of
attorney fees under 35 U.S.C. § 285; if it prevails,
Nycomed may argue to the Court that the case is
exceptional, and may proffer Glenmark's alleged
misconduct in connection with its ANDA filing and
certification, as well as in this litigation. 10 Nycomed may
not, however, use its quest for attorney fees as a hook on
which to hang an unarticulated and legally defective
claim for willful infringement.
10 As previously noted, see supra note 5, the
Court expresses no view on the merits of
Nycomed's allegations of misconduct.
C. Bad Faith and Unclean Hands
Finally, Nycomed seeks to amend the complaint to
add allegations of bad faith and unclean hands, based on
"Glenmark's submission of false and misleading
information [*19] to the FDA . . . and the withholding of
critical information from the Court and Nycomed."
9/18/09 Pl. Mot. at 1; see id. Ex. A PP 78-147. The Court
has already addressed Nycomed's allegations of litigation
misconduct, and has concluded that they do not give rise
to a separate cause of action for willful infringement. 11
Nycomed cannot alter this conclusion simply by affixing
a different label to its count. Significantly, Nycomed cites
no authority to support its assertion of a claim for "Bad
Faith and Unclean Hands." On the contrary, Nycomed
seeks to justify its inclusion of allegations of litigation
misconduct by characterizing them as "evidence of
exceptional case . . . ." 9/18/09 Pl. Mot. at 2. Consistent
with the rationale of Glaxo Group, Nycomed's assertions
of litigation misconduct may be presented on a motion
for fees should Nycomed prevail. See Glaxo Group, 376

F.3d at 1350. Those allegations do not, however, give
rise to a separate cause of action, by whatever name.
11 See supra pp. 9-11.
Nycomed's allegations of misconduct before the
FDA likewise fail to state a legally cognizable claim.
According to Nycomed, "Glenmark made material and
false and misleading omissions and misrepresentations
[*20] to the FDA concerning the bioequivalence clinical
study that forms the basis of its ANDA." 9/18/09 Pl. Mot.
at 2. Specifically, Nycomed charges that that study was
performed "in an invalid fashion that is not permitted by
the FDA or by any acceptable standards of clinical study
practice and Glenmark significantly deviated from its
study protocol." Id. This Court agrees with Glenmark that
"this is nothing more than a transparent attempt to
enforce FFDCA provisions and underlying FDA
regulations through a private cause of action." 9/29/09
Def. Opp. at 1.
Nycomed's attempt to plead a claim for misconduct
before the FDA contravenes clear and controlling
authority that [HN10] private parties cannot bring such
actions under the guise of the Hatch-Waxman Act. See
Minn. Mining & Mfg. Co. v. Barr Labs., Inc., 289 F.3d
775, 777 (Fed. Cir. 2002) (holding that the provision of
the Hatch-Waxman Act governing certifications by
ANDA filers "cannot be enforced by a private party in a
patent infringement action, but must be enforced, if at all,
only in the context of an action under the Administrative
Procedure Act ('APA')"); Andrx Pharms., Inc. v. Biovail
Corp., 276 F.3d 1368, 1376 (Fed. Cir. 2002) (a claim
[*21] of improper conduct in an FDA proceeding could
not be raised under the FFDCA but would have to be
raised initially before the FDA and thereafter in a judicial
review proceeding brought under the APA); Mylan
Pharms. v. Thompson, 268 F.3d 1323, 1332 (Fed. Cir.
2001) (holding that generic drug applicant could not
assert a private cause of action challenging the FDA's
listing of a particular name-brand drug); see also
AstraZeneca AB v. Mut. Pharm. Co.., 221 F. Supp. 2d
528, 534 (E.D. Pa. March 12, 2002) (rejecting patentees'
argument that "inadequate notice [under the
Hatch-Waxman Act by an ANDA filer] constitutes an
actionable violation under the Hatch-Waxman Act";
patentees failed to provide any authority for their claim
"that poor notice, in and of itself, allows the court to
order the withdrawal of an ANDA application or to notify
the FDA that it has not fulfilled the notice requirement").

Page 11
2010 U.S. Dist. LEXIS 29267, *21

As the Federal Circuit declared in Mylan
Pharmaceuticals: "We see nothing in the Hatch-Waxman
Amendments to alter the statement in section 337(a) of
the FFDCA that 'all such proceedings for the
enforcement, or to restrain violations, of this chapter shall
be by and in the name of the United States.' [*22] 21
U.S.C. § 337(a) (1994)." Mylan Pharms., 268 F.3d at
1332.
Nycomed makes no attempt to distinguish the
foregoing Federal Circuit precedent, nor does it provide
any caselaw sustaining similar private causes of action.
Complaining
that
Glenmark
"mischaracterize[s]
Nycomed's bad faith and unclean hands allegations as a
claim seeking to enforce FDA regulations," 11/20/09 Pl.
Supp. at 1, Nycomed cites a series of statutory provisions
dealing with criminal violations -- and thereby
underscores the correctness of Glenmark's objections. See
9/18/09 Pl. Letter at 2 (citing 21 U.S.C. § 335, and 18
U.S.C. §§ 371, 1001, and 1501). 12 Nycomed's argument
overlooks the firmly established principle that criminal
statutes generally cannot be enforced by civil actions.
See, e.g., United States v. Claflin, 97 U.S. 546, 547, 24 L.
Ed. 1082 (1878) (statute that provided a penalty for
fraudulently or knowingly importing goods contrary to
law "contemplated a criminal proceeding, and not a civil
action of debt"); Official Publ'ns, Inc. v. Kable News Co.,
884 F.2d 664, 667 (2d Cir. 1989) (mail and wire fraud
statutes "do not provide a private right of action").
12 Section 335 of Title 21, United States Code,
entitled "Hearing [*23] before report of criminal
violation," provides that before referring a
violation of the FFDCA to a United States
Attorney's Office for criminal prosecution, the
Secretary of Health and Human Services must
give the target notice and an opportunity to be
heard. See 21 U.S.C. § 335. The three provisions
of the federal criminal code cited by Nycomed
likewise in no way purport to create private
causes of action. See 18 U.S.C. § 371 (making it a
crime to conspire to commit a federal offense or
to defraud the United States or any agency
thereof); 18 U.S.C. § 1001 (making it a crime to
make a materially false representation, or conceal
a material fact, in a matter within the jurisdiction
of a branch of the federal government); 18 U.S.C.
§ 1501 (making it crime to assault or resist a
person attempting to serve a legal writ or process
of a federal court). With respect to the latter, the

Court assumes that Nycomed intended to cite 18
U.S.C. § 1505, which makes it a crime to obstruct
proceedings before federal departments and
agencies.
In its supplemental submission, Nycomed devises
two new arguments. First, Nycomed cites a series of
cases addressing "the inherent power of the court to
impose sanctions [*24] for bad-faith conduct." 11/20/09
Pl. Supp. at 3. However, that inherent power extends to
abusive litigation practices, and not to alleged misconduct
before an administrative agency. Moreover, a court's
power to levy sanctions for litigation abuses does not
create a corresponding cause of action, and none of the
cited cases holds otherwise. Nycomed had the right to
move for sanctions based on Glenmark's alleged
withholding of documents in this case; it did so, the Court
ruled, and Nycomed continues to litigate this issue ad
nauseum. The Court's "inherent powers" do not entitle
Nycomed to pursue a "claim" for discovery misconduct.
As its latest alternative legal theory, Nycomed relies
on the language of [HN11] 35 U.S.C. § 271(e)(4)(B),
which provides that "injunctive relief may be granted
against an infringer to prevent the commercial
manufacture, use, offer to sell, or sale within the United
States or importation into the United States of an
approved drug . . . ." 35 U.S.C. § 271(e)(4)(B); see
11/20/09 Pl. Supp. at 2; see also 12/4/09 Tr. at 25-27.
Nycomed ignores the plain language of that provision,
which provides that "[f]or an act of infringement,"
including the filing of an ANDA for an [*25] infringing
drug, the court may grant such injunctive relief "against
an infringer . . . ." 35 U.S.C. § 271(e)(4)(B) (emphasis
added). In other words, an injunction may be granted to
prevent the commercial manufacture, use, sale or
importation of a drug that has been found to be
infringing. In contrast, Nycomed's demand for equitable
relief, such as "[a]n Order directing the Parties to inform
the FDA of the materially false and misleading omissions
and misrepresentations in Glenmark's ANDA," and "[a]n
Order requiring Glenmark to withdraw its ANDA," 13 is
independent of Nycomed's infringement claims;
Nycomed would have the Court grant such relief on the
basis of Glenmark's alleged violations of FDA
regulations and criminal statutes, regardless of whether or
not Glenmark is guilty of patent infringement. Section
271(e)(4)(B) does not authorize such relief or such a
cause of action.

Page 12
2010 U.S. Dist. LEXIS 29267, *25

13 See Am. Compl. at p. 33.
It is hornbook law that [HN12] "private rights of
action to enforce federal law must be created by
Congress," and that a court's search for congressional
intent begins and often ends with the text and structure of
the statute at issue. Alexander v. Sandoval, 532 U.S. 275,
286, 289, 121 S. Ct. 1511, 149 L. Ed. 2d 517 (2001).
[*26] Where, as here, the statute empowers an agency to
enforce its regulations, the Court will not assume that
Congress intended to authorize by implication additional
judicial remedies for private citizens suing to enforce
those regulations. See id. at 289; Middlesex County
Sewerage Auth. v. Nat'l Sea Clammers Ass'n, 453 U.S. 1,
14-15, 101 S. Ct. 2615, 69 L. Ed. 2d 435 (1981).
Accordingly, Nycomed does not state a legally
cognizable claim for "bad faith and unclean hands" based
on Glenmark's alleged misconduct before the FDA.
Finally, it bears noting that the inclusion of
Nycomed's allegations of misconduct before the FDA are
merely a pretext for putting this information before that
agency. During oral argument, Nycomed's counsel stated:
We're not asking for a private cause of
action, we're not asking for relief against
the FDA. . . . [W]e have these documents
that show [Glenmark] did the fraud. The
FDA should be informed about that.
12/4/09 Tr. at 12. The Court then asked if the instant
dispute is really about "whether or not the protective
order should be modified or designations should be
modified so that you're authorized as opposed to directed
to inform the FDA?" Id. Plaintiff's counsel agreed:
"That's what we mean, that's [*27] better said." Id. 14

[HN13] Rule 8 of the Federal Rules of Civil
Procedure requires that a complaint "contain . . . a short
and plain statement of the claim showing that the pleader
is entitled to relief." Fed. R. Civ. P. 8(a)(2). The Second
Circuit has declared that "[t]he statement should be short
because '[u]nnecessary prolixity in a pleading places an
unjustified burden on the court and the party who must
respond to it because they are forced to select the relevant
material from a mass of verbiage.'" Salahuddin v. Cuomo,
861 F.2d 40, 42 (2d Cir. 1988) (quoting 5 Wright &
Miller, Federal Practice & Procedure § 1281, at 365
(1969)); [*28] accord Jones v. Nat'l Commc'ns &
Surveillance Networks, 266 F.App'x 31, 32 (2d Cir. Feb.
21, 2008); Infanti v. Scharpf, No. 06 CV 6552 (ILG),
2008 U.S. Dist. LEXIS 45501, 2008 WL 2397607, at *1
(E.D.N.Y. June 10, 2008). To ameliorate this problem, the
district court "has the power, on its own initiative or in
response to a motion by the defendant, to strike any
portions [of a pleading] that are redundant or immaterial,
see Fed.R.Civ.P. 12(f), or to dismiss the complaint."
Salahuddin, 861 F.2d at 42; see In re Merrill Lynch &
Co. Research Reports Sec. Litig., 218 F.R.D. 76, 78
(S.D.N.Y. 2003).
As in the case of Pappas v. Bank of America Corp.,
309 F.App'x 536, 539 (2d Cir. Feb. 17, 2009), the
problems with each of the three proposed new claims
should have been apparent to Nycomed before moving to
add them to the complaint. Because the three claims
could not survive a motion to dismiss, and the supporting
factual allegations would be stricken as immaterial under
Rule 12(f), Nycomed's motion to amend the complaint
should be denied as futile, except that Nycomed may add
to the section entitled "Relief Sought" a demand for
attorney fees under 35 U.S.C. § 285.
II. Glenmark's Motion to Amend

14 This Court has since dealt directly with the
problem of overdesignation of allegedly
confidential information. See Memorandum and
Order (March 8, 2010), D.E. # 250.
Stated differently, Nycomed has improperly used its
motion to amend as a vehicle by which it seeks to air its
various grievances against Glenmark, despite their lack of
connection to any valid cause of action. Simply put,
Nycomed's proposed pleading is "littered with
unnecessary . . . language in the nature of trash-talking."
Roberto's Fruit Mkt. v. Schaffer, 13 F.Supp.2d 390, 396
(E.D.N.Y. 1998).

Glenmark seeks to amend its [*29] already amended
answer in order to substitute a new counterclaim and
affirmative defense alleging that Nycomed engaged in
inequitable conduct before the PTO. Specifically, the
proposed pleading asserts that Nycomed falsely
represented to the PTO that results of testing
unexpectedly established that Nycomed's fluticasone
propionate (Cutivate(R)) lotion exhibited greater
vasoconstriction (potency) than the prior art fluticasone
propionate cream. Glenmark further alleges in its
proposed pleading that the information furnished to the
PTO was intentionally false, and was contrary to

Page 13
2010 U.S. Dist. LEXIS 29267, *29

information previously provided to the FDA, in
connection with the New Drug Application ("NDA")
filing for Cutivate(R) lotion; the FDA had been advised
of the results of a 1998 study (FPLA 1001) that showed
no statistical difference in the efficacy of the fluticasone
creams and lotions. According to Glenmark, the false
information provided to the PTO misled the Patent
Examiner into withdrawing rejections of the patent based
on obviousness. See Second Am. Ans. (Counterclaims)
PP 55-72. Based on the aforesaid allegations, Glenmark
proposes to assert an affirmative defense that "[p]laintiff's
claims are unenforceable [*30] due to inequitable
conduct," id. (Affirmative Defenses) P 79, and a
corresponding counterclaim. See id. (Counterclaims) PP
149-52.
Nycomed opposes Glenmark's motion to amend on
several grounds: that the request is untimely, highly
prejudicial to Nycomed, and fails to meet the pleading
standards mandated by Rule 9(b) of the Federal Rules of
Civil Procedure, as construed by the Federal Circuit in
Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312
(Fed. Cir. 2009). See 11/18/09 Pl. Opp. at 1-3, D.E. #
194. For the reasons discussed below, this Court
disagrees.
A. Timeliness
Noting that fact discovery closed on August 17,
2009, Nycomed complains that Glenmark's application is
"extremely belated," coming "more than three months
after it completed all of the discovery that it claimed it
needed." 11/18/09 Pl. Opp. at 1, 2 (emphasis in original);
see 12/4/09 Tr. at 84 (stating that Glenmark's delay is
"way too long"). In an argument raised for the first time
at oral argument, Nycomed asserts that the absence of
prejudice "isn't important in the Second Circuit" in
determining whether to grant leave to amend. See 12/4/09
Tr. at 81 (citing Parker v. Columbia Pictures Indus., 204
F.3d 326 (2d Cir. 2000); [*31] Oppenheimer v. Metal
Mgt., Inc., No. 08 Civ. 3697 (LTS)(FM), 2009 U.S. Dist.
LEXIS 71608, 2009 WL 2432729 (S.D.N.Y. July 31,
2009)). Nycomed's argument rests on a distorted reading
of the law in this circuit.
In Parker, the Second Circuit considered the
interplay between Rule 15(a), which provides that leave
to amend shall be "freely give[n]," Fed. R. Civ. P. 15(a),
and [HN14] Rule 16(b), which now provides that
scheduling orders -- including provisions limiting the
time for amending the pleadings -- "may be modified

only for good cause and with the judge's consent." Fed.
R. Civ. P. 16(b). The Second Circuit held in Parker that
[HN15] "despite the lenient standard of Rule 15(a), a
district court does not abuse its discretion in denying
leave to amend the pleadings after the deadline set in the
scheduling order where the moving party has failed to
establish good cause." Parker, 204 F.3d at 340.
Although he was on notice of the information
supporting the proposed amendment at the time he
commenced the lawsuit, the plaintiff in Parker did not
seek leave to amend until after the defendant moved for
summary judgment. The district court therefore found
that the plaintiff had not demonstrated cause for failing to
comply with the court's [*32] deadline, and it refused to
allow him to amend. See id. at 340-41. On appeal, the
Second Circuit concluded that the district court "did not
abuse its discretion in denying the request on the basis of
untimeliness." Id. at 339.
Relying on Parker and Magistrate Judge Maas'
opinion in Oppenheimer, 2009 U.S. Dist. LEXIS 71608,
2009 WL 2432729, at *2, Nycomed argues that "the mere
absence of prejudice is not sufficient to satisfy the good
cause requirement of Rule 16(b)." 12/4/09 Tr. at 81.
Nycomed overlooks the fact that in deciding whether to
grant leave to amend, a court is not required to consider
Rule 16(b) in isolation. As the court observed in Calabro
v. Stone, No. CV 2003-4522 CBA MDG, 2005 U.S. Dist.
LEXIS 5527, 2005 WL 327547 (E.D.N.Y. Jan. 27, 2005):
[HN16] "[T]he Second Circuit in Parker did not mandate
that the 'good cause' standard automatically apply in
every case, but rather, upheld a trial court's discretion to
deny a late application for failing to meet the 'good cause'
requirement under Rule 16(b)." Id. at *1 (emphasis in
original); accord Bridgeport Music, Inc. v. Universal
Music Group, Inc., 248 F.R.D. 408, 412 (S.D.N.Y. 2008).
In fact, in an opinion that post-dates Parker, the Second
Circuit expressly noted that the moving party's [*33]
diligence "is not . . . the only consideration," and that the
district court, in exercising its "discretion under Rule
16(b), also may consider other relevant factors including,
in particular, whether allowing the amendment of the
pleading at this stage of the litigation will prejudice" the
opposing party. Kassner v. 2nd Ave. Delicatessan Inc.,
496 F.3d 229, 244 (2d Cir. 2007); accord Jackson v.
Roslyn Bd. of Educ., 596 F.Supp.2d 581, 585 (E.D.N.Y.
2009); see also Holmes v. Grubman, 568 F.3d 329,
334-35 (2d Cir. 2009) (stating that "the lenient standard
under Rule 15(a) . . . must be balanced against" the

Page 14
2010 U.S. Dist. LEXIS 29267, *33

requirements of Rule 16(b)). Thus, "the Court [of
Appeals] left open the possibility that amendments could
be permitted even where a plaintiff had not been diligent
in seeking an amendment," inasmuch as "both Rules
should be considered simultaneously" and the factors
balanced. Castro v. City of New York, No. 06-CV-2253
(RER), 2010 U.S. Dist. LEXIS 19935, 2010 WL 889865,
at *2 (E.D.N.Y. March 6, 2010).
In this case, after balancing the Rule 16(b) and Rule
15(a) considerations, the Court rejects Nycomed's
timeliness challenge.
1. Glenmark's Diligence
The deadline for amending the pleadings in this case
was June 2, [*34] 2009. See Schedule (Feb. 17, 2009),
D.E. # 30-1. Glenmark argues that it did not become
aware of the inconsistent representations to the FDA and
PTO until depositions that were held at the end of July
2009, see 12/4/09 Tr. at 65, and that it waited for this
Court to rule on its motion to compel related answers to
interrogatories before seeking permission to amend. See
id. at 65-66; 11/13/09 Def. Mot. at 3. 15 Nycomed
counters that this purported justification "makes no
sense": While "Glenmark is essentially arguing that it
waited all this time because it did not have sufficient
discovery to support the counterclaim," it nevertheless is
now seeking to add those allegations despite the fact that
the Court denied its request for the awaited discovery.
See 11/18/09 Pl. Opp. at 2.
15 The motion was denied on October 20, 2009.
See Memorandum and Order (Oct. 20, 2009), at 4,
D.E. # 185.
Glenmark cannot be faulted for failing to comply
with the June 2nd deadline for amending the pleadings;
like Nycomed, it did not acquire the information
underlying the proposed amendment until after the
expiration of that deadline. 16 Nycomed does not dispute,
and the Court finds, that Glenmark had good cause [*35]
for failing to move before the June 2nd deadline. In
essence, what Nycomed complains of is not Glenmark's
failure to comply with the deadline, but rather its failure
to move sooner after the deadline.
16 Nycomed's motion to amend -- which was
still pending when Glenmark filed its
cross-motion -- was likewise filed after the June
2nd deadline for amending the pleadings, as well

as after the August 17th deadline for fact
discovery. See 9/18/09 Pl. Mot. Moreover,
Glenmark's motion preceded (by one week)
Nycomed's letter-brief supplementing its own
motion to amend the complaint. See 11/13/09
Def. Mem.; 11/20/09 Pl. Supp.
Although the justification proffered by Glenmark
cannot be characterized as compelling, it is not, as
Nycomed suggests, irrational. That Glenmark preferred to
have additional discovery before drafting its amended
pleading is entirely understandable, and a three-month
delay does not qualify as "extremely belated," 11/18/09
Pl. Opp. at 1, especially when contrasted with far longer
delays that have been tolerated by courts in granting
motions to amend. See Margel v. E.G.L. Gem Lab Ltd.,
No. 04 Civ. 1514(PAC)(HBP), 2010 U.S. Dist. LEXIS
10622, 2010 WL 445192, at *10 (S.D.N.Y. Feb. 8, 2010)
(granting motion [*36] to amend despite delay of at least
six months; collecting Second Circuit cases allowing
amendments after delays ranging from two to five years);
Pall Corp. v. Cuno Inc., 681 F. Supp. 2d 258, 2010 U.S.
Dist. LEXIS 4175, 2010 WL 301954, at *5 (E.D.N.Y.
2010) (although the two related cases had been pending
for twelve and six years, no trial date had yet been set);
see also Johnson & Johnson v. Guidant Corp., No. 06
Civ. 7685(RJS), 2010 U.S. Dist. LEXIS 13936, 2010 WL
571814, at *6 n.7 (S.D.N.Y. Feb. 16, 2010) (although
Rule 16(b) deadline for amending the pleadings had
expired nearly one year earlier, court would reach the
merits of plaintiff's motion to amend); Zomba Recording
Corp. v. MP3.com, Inc., No. 00 Civ. 6831(JSR), 2001
U.S. Dist. LEXIS 9647, 2001 WL 770926, at *1 (S.D.N.Y.
July 10, 2001) (despite "extended delay," court exercises
its discretion to allow amendment in the absence of
prejudice). Notwithstanding Parker, the Second Circuit
has not abrogated the principle that delay alone, in the
absence of bad faith or prejudice, is usually not sufficient
reason for denying a motion to amend. See Parker, 204
F.3d at 339; Ruotolo v. City of New York, 514 F.3d 184,
191 (2d Cir. 2008). The Court therefore turns to
Nycomed's claim of prejudice.
2. Prejudice
[HN17] "The [*37] party opposing the motion for
leave to amend has the burden of establishing that an
amendment would be prejudicial." Kirkland v. City of
New York, No. 06 CV 0331(NG)(CLP), 2007 U.S. Dist.
LEXIS 38374, 2007 WL 1541367, at *3 (E.D.N.Y. May

Page 15
2010 U.S. Dist. LEXIS 29267, *37

25, 2007) (internal quotation and citation omitted).
Nycomed argues that it will be "highly prejudiced" if the
amendment is allowed, because the facts necessary to
Nycomed's defense to such inequitable conduct
allegations reside with third parties, such as the original
applicants/owners of the '669 Patent, the original
inventors of the '669 Patent, the attorneys who drafted
the application, and the FPLA 1001 investigators. 17
11/18/09 Pl. Opp. at 2. When the Court inquired at oral
argument whether the prejudice would be mitigated if the
Court reopened discovery, Nycomed's counsel avoided a
direct response, and instead asserted -- incorrectly -- that
"[p]rejudice isn't important . . . ." 12/4/09 Tr. at 81; but
see supra pp. 20-21.

from the rule broadly allowing amendment to
pleadings"). This principle applies with particular force
where, as here, "trial has not yet commenced and is not
likely to do so for some time." S.S. Silberblatt, 608 F.2d
at 42. The fact that discovery has ended does not alter
this conclusion. See Hampton Bays Connections, 212
F.R.D. at 123. "The prejudice that would flow from any
additional required discovery can generally be mitigated
by adjustments to the discovery schedule." Margel, 2010
U.S. Dist. LEXIS 10622, 2010 WL 445192, at *12; accord
Calabro, 2005 U.S. Dist. LEXIS 5527, 2005 WL 327547,
at *2 (finding "no prejudice since defendant will be given
an opportunity to conduct discovery" regarding the new
claim).

17 Nycomed also includes the Patent Examiner
on its list. See 11/18/09 Pl. Opp. at 2. However,
discovery of the Patent Examiner is not permitted.
See W. Elec. Co., Inc. v. Piezo Tech., 860 F.2d
428, 432 (Fed. Cir. 1988) (patent examiners are
quasi-judicial [*38] officials who cannot be
compelled to testify regarding their mental
processes in reaching a decision on a patent
application).

Judged by these standards, Nycomed's claim of
prejudice is unavailing. In the circumstances presented,
where the Court is prepared to reopen discovery to allow
Nycomed to obtain the information needed to meet the
new allegations, Nycomed has identified no legally
cognizable prejudice. Although discovery has closed, no
trial date has been set and none is likely [*40] to be set in
the near future, while Nycomed relentlessly presses for
discovery sanctions and/or additional discovery regarding
Glenmark's electronically stored information, and while
the parties litigate the propriety of the Court's order
striking the Markman submissions, as well as the
appointment of a special master. 18 In short, this case is
hardly at an advanced stage of litigation and Nycomed
has exhibited no eagerness to accelerate the pace of these
proceedings. To reopen discovery on the inequitable
conduct allegations would not unduly delay the case or
unfairly disadvantage Nycomed. The Court therefore
rejects Nycomed's timeliness challenge and reaches the
merits of its argument that the proposed amendment
would be futile. See generally Jackson, 596 F.Supp.2d at
586 (despite five-month delay, which the court
characterizes as "some evidence of a lack of diligence,"
the court reaches the merits of plaintiff's proposed new
claim: "Although the plaintiff was slow to file the instant
motion, the claimed prejudice is not the type of prejudice
that the Court regards as a bar to amendment.").

[HN18] "The type of prejudice that warrants denial
of leave to amend is usually such that it puts [the
opposing party] at an unfair disadvantage," such as the
addition of a new claim on the eve of trial. See In re
Osage Exploration Co., 104 F.R.D. 45, 49 (S.D.N.Y.
1984); see Monahan v. New York City Dep't of Corr., 214
F.3d 275, 284 (2d Cir. 2000) ("[W]e will be most hesitant
to allow amendment where doing so unfairly surprises the
non-movant and impedes the fair prosecution of the
claim."); Margel, 2010 U.S. Dist. LEXIS 10622, 2010 WL
445192, at *11 (court allows plaintiffs to amend to assert
new theory, because "it will not result in an undue
burden") (collecting cases). In this regard, "the need to
conduct additional discovery is not, in itself, sufficient to
constitute prejudice." Margel, 2010 U.S. Dist. LEXIS
10622, 2010 WL 445192, at *12 (citing, inter alia, S.S.
Silberblatt, Inc. v. East Harlem Pilot Block, 608 F.2d 28,
43 (2d Cir. 1979)); accord Lawrence v. Starbucks Corp.,
No. 08 Civ. 3734(LTS)(JCF), 2009 U.S. Dist. LEXIS
114909, 2009 WL 4794247, at *4 (S.D.N.Y. Dec. 10,
2009); Hampton Bays Connections, Inc. v. Duffy, 212
F.R.D. 119, 123 (E.D.N.Y. 2003); [*39] see also
Monahan, 214 F.3d at 284 ("the fact that one party has
spent time and money preparing for trial will usually not
be deemed prejudice sufficient to warrant a deviation

18 See, e.g., Plaintiff's Letter In Response to
Factual Matters Regarding Glenmark's ESI Search
[*41] (Feb. 17, 2010), D.E. # 235; Defendant's
Motion for Reconsideration Regarding Order on
Motion for Reconsideration (Jan. 4, 2010), D.E. #
214; Plaintiff's Response in Opposition to Letter
Motion to Appoint Special Master (March 3,

Page 16
2010 U.S. Dist. LEXIS 29267, *41

2010), D.E. # 247.

information with a specific intent to
deceive the PTO.

B. Futility
Nycomed next contends that Glenmark's inequitable
conduct allegations fail to meet the pleading standards
enunciated by the Federal Circuit in Exergen, 575 F.3d
1312. See 11/18/09 Pl. Opp. at 2-3. Nycomed thus
opposes Glenmark's motion to amend on the ground of
futility. As courts in this circuit have repeatedly held,
[HN19] "[t]he party opposing an amendment has the
burden of establishing that leave to amend would be
prejudicial or futile." 19 Staskowski v. County of Nassau,
05 Civ. 5984(SJF)(WDW), 2007 U.S. Dist. LEXIS 86319,
2007 WL 4198341, at *4 (E.D.N.Y. Nov. 21, 2007);
accord Margel, 2010 U.S. Dist. LEXIS 10622, 2010 WL
445192, at *3; Penn Mut. Life Ins. Co. v. Madow, No. CV
07-3188(AKT), 2009 U.S. Dist. LEXIS 25416, 2009 WL
804719, at *3 (E.D.N.Y. March 26, 2009); Lugosch v.
Congel, 00-CV-784, 2002 U.S. Dist. LEXIS 8455, 2002
WL 1001003, at *1 (N.D.N.Y. May 14, 2002);
Blaskiewicz v. County of Suffolk, 29 F.Supp.2d 134,
137-38 (E.D.N.Y. 1998); Harrison v. NBD Inc., 990
F.Supp. 179, 185 (E.D.N.Y. 1998). Nycomed has not met
its burden.
19
Regional [*42] law governs procedural
matters not unique to patent law. See, e.g.
Pressure Prods. Med. Supplies v. Greatbatch Ltd..
599 F.3d 1308, 2010 U.S. App. LEXIS 6132, 2010
WL 1051154, at *3 (Fed. Cir. March 24, 2010);
Exergen, 575 F.3d at 1318.
In Exergen, the Federal Circuit clarified the
heightened standard for pleading inequitable conduct, a
concept related to fraud. Specifically, Exergen held that
[HN20] "Rule 9(b) requires identification of the specific
who, what, when, where and how of the material
misrepresentation or omission committed before the
PTO." 575 F.3d at 1327; see id. at 1328. The court
further declared that
although 'knowledge' and 'intent' may be
averred generally, a pleading of
inequitable conduct under Rule 9(b) must
include sufficient allegations of underlying
facts from which a court may reasonably
infer that a specific individual (1) knew of
the withheld material information or of the
falsity of the material misrepresentation,
and (2) withheld or misrepresented this

Id. at 1328-29. Accordingly, "[a] pleading that simply
avers the substantive elements of inequitable conduct,
without setting forth the particularized factual bases for
the allegation, [*43] does not satisfy Rule 9(b)." Id. at
1326-27.
Glenmark's proposed amended pleading asserts the
following inequitable conduct before the PTO:
Nycomed's allegedly false representation to the PTO that
Nycomed's
fluticasone
propionate
lotion
was
unexpectedly found to exhibit greater vasoconstriction
than the prior art fluticasone propionate cream, and
Nycomed's allegedly deceitful withholding of the
contrary test results furnished to the FDA in connection
with the NDA filing for the same lotion. See Second Am.
Ans. (Counterclaims) PP 51-72. Glenmark identifies a
particular individual (Robert Anderson) alleged to have
been responsible for the omission and false statement to
the PTO: the person who conducted the due diligence
process relating to the NDA and supervised the
prosecution of the '669 Patent. Id. PP 51-63; see
11/13/09 Def. Mot. at 2.
Nycomed challenges the sufficiency of Glenmark's
allegations in several respects. First, Nycomed complains
that the proposed pleading fails to allege that Mr.
Anderson knew of the relevance of the FPLA 1001 test
results to either the '669 Patent or to arguments before
the PTO; and fails to allege that he intended to deceive or
mislead the PTO. See 11/18/09 [*44] Pl. Opp. at 3.
Additionally, Nycomed argues that Glenmark "never
acquired any proof that a material misrepresentation or
omission occurred." Id.
a. Materiality
Nycomed's materiality challenge can be swiftly
rejected. [HN21] Information is considered material
where either (a) "there is a substantial likelihood that a
reasonable examiner would consider it important in
deciding whether to allow the application to issue as a
patent," Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d
1359, 1364 (Fed. Cir. 2007) (citing 37 C.F.R. § 1.56(a)
(1991)); or (b) it falls within the standards set forth in
PTO Rule 56, which provides in pertinent part that
"[i]nformation is material to patentability when it is not
cumulative to information already of record or being
made of record in the application, and . . . (2) [i]t refutes,

Page 17
2010 U.S. Dist. LEXIS 29267, *44

or is inconsistent with, a position the applicant takes in:
(i) [o]pposing an argument of unpatentability relied on by
the [PTO], or (ii) [a]sserting an argument of
patentability." Cargill, 476 F.3d at 1364 (quoting 37
C.F.R. § 1.56(b) (2006)). See generally Pall Corp.,
F.Supp.2d
, 2010 U.S. Dist. LEXIS 4175, 2010 WL
301954, at *2-3. Clearly, when measured against either
of these standards, Nycomed's alleged
[*45]
misrepresentation and omission were not only material
but highly material.
According to Glenmark's proposed pleading, the
statements Nycomed made to the PTO concerning the
relative potencies of the fluticasone propionate lotion and
prior art cream directly contradicted the data from and
conclusions of study FPLA 1001, which were
communicated to the FDA in connection with the same
lotion product but were intentionally withheld from the
PTO. See Second Am. Ans. (Counterclaims) PP 60-66;
see also 11/13/09 Def. Mot. at 2. Glenmark further avers
that on July 26, 2007, after the PTO Examiner had on
several occasions rejected the claims as obvious,
Nycomed, in order to overcome those rejections,
amended its patent application to include for each
pending claim a limitation based on the supposed
unexpected increased vasoconstriction. See Second Am.
Ans. (Counterclaims) PP 43-44, 52-54, 67-72; 11/13/09
Def. Mot. at 2. In fact, in issuing a Notice of Allowance
and withdrawing the PTO's rejection for obviousness, the
Patent Examiner expressly cited Nycomed's arguments
concerning the lotion's unexpected greater potency as
compared with the prior art cream. See Second Am. Ans.
(Counterclaims) PP [*46] 75-76; 11/13/09 Def. Mot. at
2. Glenmark's particularized allegations of materiality
thus bear no resemblance to those found wanting in
Exergen. There the court concluded that the alleged
infringer's generalized pleading that "the withheld
references are 'material' and 'not cumulative'" was
defective, in that those allegations failed to explain "'why'
the withheld information [was] material and not
cumulative, and 'how' an examiner would have used this
information in assessing the patentability of the claims."
Exergen, 575 F.3d at 1329-30. In contrast, in the instant
case, Glenmark's pleading explains "why" the alleged
omission and misrepresentation are material and the latter
not cumulative; "where" the misrepresentation and
omission can be found; and "how" the examiner would -and in fact did -- rely on the false information (and the
absence of the contrary test results) in withdrawing the
prior rejection of the claims and stating the PTO's reasons

for allowing the patent. Any challenge to the materiality
of the allegedly false or withheld information is plainly
frivolous.
b. Intent to Deceive
Nycomed additionally objects that the proposed
pleading fails to allege sufficient knowledge [*47] and
intent on the part of Mr. Anderson, the person identified
in Glenmark's inequitable conduct allegations. This Court
disagrees.
Glenmark asserts that in connection with Nycomed's
predecessor's acquisition of the Cutivate(R) line of
products, Mr. Anderson -- who later supervised the
prosecution of the '669 Patent -- was responsible for
conducting the due diligence inquiry concerning the
corresponding NDA. See Second Am. Ans.
(Counterclaims) PP 58-59; 11/13/09 Def. Mot. at 2.
According to Glenmark, Mr. Anderson thus became
aware of the results of study FPLA 1001, as reported to
the FDA, and was aware of the contrary statements
submitted to the PTO in July 2007, under his supervision,
with intent to deceive. See Second Am. Ans.
(Counterclaims) PP 60, 63, 68-69; 11/13/09 Def. Mot. at
2. Accordingly, Glenmark's pleading particularizes the
"who, what, when, where and how" of the material
misrepresentation and omission committed before the
PTO.
Again citing Exergen, and Mr. Anderson's
exculpatory deposition testimony, Nycomed argues that
the facts alleged in Glenmark's proposed pleading do not
support an inference of an intent to deceive. See 11/18/09
Pl. Opp. at 3. However, the Federal [*48] Circuit has
long recognized that [HN22] "[i]ntent rarely can be, and
need not be, proven by direct evidence. Instead, an intent
to deceive is usually inferred from the facts and
circumstances surrounding the conduct at issue." Cargill,
476 F.3d at 1364 (citations omitted). Furthermore, "[t]he
more material the omission or the misrepresentation, the
lower the level of intent required to establish inequitable
conduct, and vice versa." Id. (quoting Critikon, Inc. v.
Becton Dickinson Vascular Access, Inc., 120 F.3d 1253,
1256 (Fed. Cir. 1997)); accord Pall Corp.,
F.Supp.2d
, 2010 U.S. Dist. LEXIS 4175, 2010 WL 301954, at *2.
In Exergen, the pleading was so devoid of specific
facts that the court could not ascertain the materiality of
the withheld references or the identity of any specific
individual alleged to have knowledge of the withheld

Page 18
2010 U.S. Dist. LEXIS 29267, *48

material information. See Exergen, 575 F.3d at 1329-30.
In those circumstances, the court concluded that no facts
were alleged from which one could reasonably infer the
requisite intent to deceive. See id. at 1330-31. Here,
however, Glenmark has adequately pled sufficient facts
to support an inference of scienter. Significantly, the
proposed pleading asserts that the allegedly [*49] false
information was provided in response to the Patent
Examiner's rejections of the patent based on obviousness,
and the FPLA 1001 study results were withheld for the
same reason. As the Federal Circuit has acknowledged,
[HN23] "intent may be inferred where a patent applicant
knew . . . that withheld information would be material to
the PTO's consideration of the patent application,"
especially where, as here, "the examiner repeatedly raises
an issue to which the information relates." Cargill, 476
F.3d at 1366 (citing Critikon, 120 F.3d at 1256); accord
Pall Corp., F.Supp.2d , 2010 U.S. Dist. LEXIS 4175,
2010 WL 301954, at *3.
Faced with a similar challenge to a motion to amend,
another court in this circuit distinguished Exergen and
permitted the defendant to add allegations of inequitable
conduct:
Unlike the situation in Exergen, where
the pleading stated generally that the
corporation was aware of two patents but
provided no factual basis to infer that any
specific individual knew of specific
information in the patents that was
material to the claims of the patent-in-suit,
[the defendant] has specifically alleged the
individuals involved, the information
withheld and why it was material.
Evidence that [the [*50] two named
inventors of the patent-in-suit] submitted a
drawing to the PTO that omitted the
features that allegedly rendered the
pending claims unpatentable could give
rise to an inference that they did so
knowingly and with deceptive intent.
Synventive Molding Solutions, Inc. v. Husky Injection
Molding Sys., No. 2:08-CV-136, 2009 U.S. Dist. LEXIS
102031, 2009 WL 3172740, at *3 (D. Vt. Oct. 1, 2009)
(citation omitted). So too here, Glenmark's allegations
that Nycomed, under Mr. Anderson's supervision,
omitted testing results consistent with the PTO's
rejections of the claims as obvious, and made material

false statements about the results of testing, could give
rise to an inference of culpable knowledge and intent.
A recent decision from this district reached the same
result as Synventive, concluding that the defendant's
factual allegations concerning the patentee's inequitable
conduct before the PTO "amply set forth the who, what,
when, where and how of each material misrepresentation
or omission . . . ." Pall Corp., F.Supp.2d , 2010 U.S.
Dist. LEXIS 4175, 2010 WL 301954, at *5. In doing so,
the court further found that "when viewed as a whole, the
facts alleged in the proposed Amended Answer support
an inference that [the patentee] [*51] intended to deceive
the PTO . . . ." Id.
Rather than view Glenmark's factual allegations as a
whole, Nycomed challenges the sufficiency of
Glenmark's evidence, and proffers explanations as to why
Mr. Anderson would not have been aware of the FPLA
1001 study or of the source of the data submitted to the
PTO. See 11/18/09 Pl. Opp. at 3. Nycomed misconstrues
the nature of the Court's inquiry in ruling on a motion to
amend:
[HN24] In making this determination,
the Court should not consider the merits of
a claim or defense unless the amendment
is "clearly frivolous or legally insufficient
on its face . . . . If the [movant] has at least
colorable grounds for relief, justice . . .
require[s] that the court grant leave to
amend . . . ."
Pall Corp., F.Supp.2d , 2010 U.S. Dist. LEXIS 4175,
2010 WL 301954, at *4 (quoting Blaskiewicz v. County of
Suffolk, 29 F.Supp.2d 134, 138 (E.D.N.Y. 1998)).
Glenmark's proposed amendments satisfy these
standards. Nycomed's challenge to the sufficiency of
Glenmark's proof of scienter "attack[s] the merits of
[Glenmark's] inequitable conduct claim, not whether the
claim has been adequately pled." Synventive, 2009 U.S.
Dist. LEXIS 102031, 2009 WL 3172740, at *3. However,
"[w]hether or not [Glenmark's] counterclaim [and [*52]
affirmative defense] for unenforceability due to
inequitable conduct can survive summary judgment
awaits the appropriate motion." Id. at *3; see HTC Corp.
v. IPCom Gmbh & Co., KG, 671 F.Supp.2d 146, 151
(D.D.C. 2009) (patentee's arguments "that the prior art
references are lengthy and [the alleged infringer] has not
proven that the named inventors read the [relevant] pages

Page 19
2010 U.S. Dist. LEXIS 29267, *52

. . . confuse the burdens of proof at trial with the pleading
requirements of Rule 9(b)").
This Court's rejection of Nycomed's arguments is
consistent with the recent rulings of various district courts
in interpreting and applying Exergen. In fact, in a
decision issued about a month ago by the Eastern District
of Michigan, the court reviewed a number of those cases
and observed that "[a]ll of these district court holdings
found that inequitable conduct affirmative defenses were
sufficiently pled -- on far fewer facts than those advanced
by" the defendant in that case. Somanetics Corp. v. CAS
Med. Sys., Inc.,
F.Supp.2d , 2010 U.S. Dist. LEXIS
17006, 2010 WL 729021, at *4 (E.D. Mich. Feb. 25,
2010) (emphasis in original); see id. at *4-5 (discussing
WesternGeco v. Ion Geophysical Corp., Civil Action No.
09-CV-1827, 2009 U.S. Dist. LEXIS 100277, 2009 WL
3497123, at *7 (S.D. Tex. Oct. 28, 2009) [*53] ([HN25]
"The heightened pleading requirements of Rule 9(b) do
not require that [the allege infringer] prove the merits of
its claim. What is determinative here is that [the patentee]
was given fair notice of the basis for [the alleged
infringer's] inequitable conduct defense."); Power
Integrations, Inc. v. Fairchild Semiconductor Int'l, Inc.,
Civ. No. 08-309-JJF-LPS, 2009 U.S. Dist. LEXIS
118383, 2009 WL 4928024, at *8 (D. Del. Dec. 18,
2009); HTC Corp., 671 F.Supp.2d at 150-52; Konami
Digital Entm't v. Harmonix Music Sys., Inc., Civil Action
No. 6:08CV286-JDL, 2009 U.S. Dist. LEXIS 117468,
2009 WL 5061812, at *2 (E.D. Tex. Dec. 14, 2009) ("The
Federal Circuit teaches that these [factual] allegations
need not be a 'smoking gun,' but rather sufficient grounds
to infer the requisite knowledge and intent.")). Many
more post-Exergen cases can now be added to the list of
those that have repudiated arguments similar to those
advanced by Nycomed. See, e.g., CIVIX-DDI, LLC v.
Hotels.com, LP, No. 05 C 6869, 2010 U.S. Dist. LEXIS
8073, 2010 WL 431467, at *13 (N.D. Ill. Feb. 1, 2010)
(granting motion to amend; whether named individual's
representations were inconsistent "goes to whether
Defendants' factual allegations are true, not whether
Defendants have pleaded their inequitable conduct [*54]
claims and defenses with particularity under Rule 9(b),
which they have done"); The Braun Corp. v. Vantage
Mobility Int'l, LLC, Cause No. 2:06-CF-50-JVB-PRC,
2010 U.S. Dist. LEXIS 6839, 2010 WL 403749, at *8
(N.D. Ind. Jan. 27, 2010) (finding that accused infringer's
inequitable conduct allegations satisfied the Exergen
pleading standard, and rejecting the patentee's argument
that at the pleading stage - as opposed to the proof stage

-- the inference of intent to deceive had to be "the single
most reasonable inference able to be drawn from the
evidence"); WebXchange Inc. v. FedEx Corp., C.A. No.
08-133-JJF, 2010 U.S. Dist. LEXIS 4529, 2010 WL
299243, at *3 (D. Del. Jan. 20, 2010) (granting motion to
amend and ruling that factual determinations about the
named individual's knowledge and intent to deceive are
not appropriate on such a motion); Semiconductor Energy
Lab. Co. v. Samsung Elecs. Co., No. 09-CV-01-bbc, 2010
U.S. Dist. LEXIS 556, 2010 WL 55847, at *12-13 (W.D.
Wis. Jan. 5, 2010) (denying motion to dismiss inequitable
conduct counterclaims); ICU Med., Inc. v. RyMed Techs.,
Inc., 674 F. Supp. 2d 574, 2009 U.S. Dist. LEXIS 117353,
2009 WL 4884023, at *4 (D. Del. 2009) (granting
accused infringer leave to amend to add inequitable
conduct defense); Lincoln Nat'l Life v. Transamerica Fin.
Life Ins. Co., Cause No. 1:08-CV-135, 2009 U.S. Dist.
LEXIS 110599, 2009 WL 4547131, at *2-4 (N.D. Ind.
Nov. 25, 2009) [*55] (granting leave to amend, and
holding that alleged infringers' allegation that at least two
individuals knew of the withheld references during the
prosecution of the patent-in-suit, and that the references
were highly material yet were not disclosed to the
examiner, were sufficient to create a reasonable inference
of intent to deceive).
In sum, "[t]he issue before the Court is not whether
[Glenmark] will ultimately prevail, but whether it is
entitled to offer evidence" to support its allegations of
inequitable conduct. Pall Corp.,
F.Supp.2d , 2010
U.S. Dist. LEXIS 4175, 2010 WL 301954, at *4. For the
foregoing reasons, this Court concludes that it is so
entitled. By the same token, Nycomed is entitled to the
opportunity to discover evidence to defend itself against
those allegations. Accordingly, discovery will be
reopened for a short period for that limited purpose.
CONCLUSION
For the reasons detailed above, the Court
recommends that Nycomed's motion to amend its
complaint be denied, except that Nycomed may add a
demand for attorney fees in its prayer for relief; and
Glenmark's motion to amend is granted. The amended
[*56] pleadings shall be filed by March 30, 2010.
Discovery is reopened until June 1, 2010, for the limited
purpose of allowing Nycomed to take discovery
regarding Glenmark's newly added inequitable conduct
allegations.
Any

objections

to

the

rulings

and/or

Page 20
2010 U.S. Dist. LEXIS 29267, *56

recommendations in this opinion must be filed with the
Honorable Carol B. Amon on or before April 9, 2010.
Failure to file objections in a timely manner may waive a
right to appeal the District Court order.
SO ORDERED.

Dated: Brooklyn, New York
March 26, 2010
ROANNE L. MANN
UNITED STATES MAGISTRATE JUDGE